Dataset Information

A Randomized Controlled Trial of Innovative Postpartum Care Model for Mother-Baby Dyads.

ABSTRACT: OBJECTIVE:To evaluate the efficacy, safety, and maternal satisfaction of a newly established integrative postpartum community-based clinic providing comprehensive support for mothers during the first month after discharge from the hospital. Our primary interests were breastfeeding rates, readmission and patient satisfaction. METHODS:A randomized controlled trial was conducted in Ottawa, Canada, where 472 mothers were randomized via a 1:2 ratio to either receive standard of care (n = 157) or to attend the postpartum breastfeeding clinic (n = 315). Outcome data were captured through questionnaires completed by the participants at 2, 4, 12 and 24 weeks postpartum. Unadjusted and adjusted logistic regression models were conducted to determine the effect of the intervention on exclusive breastfeeding at 12 weeks (primary outcome). Secondary outcomes included breastfeeding rate at 2, 4 and 24 weeks, breastfeeding self-efficacy scale, readmission rate, and satisfaction score. RESULTS:More mothers in the intervention group (n = 195, 66.1%) were exclusively breastfeeding at 12 weeks compared to mothers in the control group (n = 81, 60.5%), however no statistically significant difference was observed (OR = 1.28; 95% CI:0.84-1.95)). The rate of emergency room visits at 2 weeks for the intervention group was 11.4% compared to the standard of care group (15.2%) (OR = 0.69; 95% CI: 0.39-1.23). The intervention group was significantly more satisfied with the overall care they received for breastfeeding compared to the control group (OR = 1.96; 95% CI: 3.50-6.88)). CONCLUSION:This new model of care did not significantly increase exclusive breastfeeding at 12 weeks. However, there were clinically meaningful improvements in the rate of postnatal problems and satisfaction that support this new service delivery model for postpartum care. A community-based multidisciplinary postpartum clinic is feasible to implement and can provide appropriate and highly satisfactory care to mother-baby dyads. This model of care may be more beneficial in a population that is not already predisposed to breastfeed. TRIAL REGISTRATION:ClinicalTrials.gov NCT02043119.

SUBMITTER: Laliberte C

PROVIDER: S-EPMC4752489 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Randomized Controlled Trial of Innovative Postpartum Care Model for Mother-Baby Dyads.

Laliberté Corinne C Dunn Sandra S Pound Catherine C Sourial Nadia N Yasseen Abdool S AS Millar David D Rennicks White Ruth R Walker Mark M Lacaze-Masmonteil Thierry T

PloS one 20160212 2

<h4>Objective</h4>To evaluate the efficacy, safety, and maternal satisfaction of a newly established integrative postpartum community-based clinic providing comprehensive support for mothers during the first month after discharge from the hospital. Our primary interests were breastfeeding rates, readmission and patient satisfaction.<h4>Methods</h4>A randomized controlled trial was conducted in Ottawa, Canada, where 472 mothers were randomized via a 1:2 ratio to either receive standard of care (n ...[more]

PMID: 26871448

Similar Datasets

Project description:Background/objectiveParents shape children's early experiences with food, influencing what is served, children's food choices, and how much children eat. Responsive parenting (RP) interventions such as INSIGHT have improved maternal infant feeding practices, but have only been tested among predominantly White families. This secondary analysis of data from the Sleep SAAF (Strong African American Families) RCT tests the effects of an RP intervention designed to prevent rapid infant weight gain on African American mothers' infant feeding practices.MethodsPrimiparous African American mother-infant dyads (n = 194) were randomized to an RP or safety control intervention delivered by community research associates at infant age 3 and 8 weeks. At 16 weeks, mothers completed the Babies Need Feeding questionnaire, the Infant Feeding Styles Questionnaire, and the Babies Need Soothing questionnaire. Logistic regression and general linear models examined the effect of study group on infant feeding practices. Moderation analyses explored whether effects varied by feeding mode (any breast milk versus exclusive formula), maternal age (≥ 20 years versus < 20 years), and maternal pre-pregnancy BMI (with obesity versus not).ResultsRP mothers reported more responsive feeding (p = 0.005, partial η2 = 0.02), lower likelihood of using beverages other than breast milk/formula to soothe their infant (p = 0.01, OR = 0.42, 95% CI [0.2-0.8]), and less pressure with cereal than control mothers (p = 0.09, partial η2 = 0.02). RP mothers also reported less pressure to finish/soothe than controls (p = 0.007, partial η2 = 0.04); feeding mode (B = 0.74, p = 0.003) and maternal age (B = 0.53, p = 0.04) moderated this effect. There were no significant group differences in bottle-feeding practices (e.g., adding cereal to bottle, using an appropriate nipple/bottle size), or in context-based or emotion-based food to soothe.ConclusionsResponsive parenting education influenced some feeding practices of African American mothers. Mothers reported using less pressure, a control-based feeding practice, and more responsive feeding than controls.Trial registrationSleep SAAF: A Strong African American Families Study. www.Clinicaltrialsgov NCT03505203. Registered 3 April 2018.

Project description:ObjectiveWith a period prevalence of 21.9% in the year after birth, depression is a common complication of childbearing. We assessed the impact of telephone-delivered depression care management (DCM) on symptom levels, health service utilization, and functional status 3, 6, and 12 months postpartum.MethodsThe randomized controlled trial was conducted at the University of Pittsburgh, Pittsburgh, Pennsylvania, from March 2006 through September 2010. Women (N = 628) who screened positive for depression (a score of 10 or greater on the Edinburgh Postnatal Depression Scale) 4 to 6 weeks postpartum were evaluated with the Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition With Psychotic Screen and enrolled in a randomized trial of DCM compared to enhanced usual care (EUC). Clinicians conducted telephone contacts to educate, assist with treatment decisions, monitor symptoms, facilitate access to services, and encourage links to community resources. Independent evaluators collected symptom scores, functional status, and health services use at 3, 6, and 12 months postpartum. Primary outcome was reduction of symptoms as measured by the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement.ResultsMean depressive symptom and function scores significantly improved (by greater than 50%) in both groups of women but did not differ by DCM versus EUC assignment. Health services use was similar in women randomly assigned to DCM compared to EUC. Women with childhood sexual abuse responded significantly more favorably to DCM on depression and functional measures (all P values < .02).ConclusionsBoth DCM and EUC favorably impacted depression symptom levels and function. The subgroup of women with childhood sexual abuse benefited significantly more from DCM compared to the EUC condition. Regular telephone availability of a clinician is a resource that appears to be particularly therapeutic to women with childhood sexual abuse.Trial registrationClinicalTrials.gov identifier: NCT00282776.

Project description:BACKGROUND:Current guidelines for the management of obesity in women planning pregnancy suggest lifestyle modification before conception. However, there is little evidence that lifestyle modification alters pregnancy outcomes. Bariatric surgery results in significant weight loss. This appears to reduce the risk of adverse pregnancy outcomes for the mother but may increase the risk of adverse outcomes for the infant. In order to reduce the risks of obesity-related adverse pregnancy outcomes for both mother and offspring, alternative approaches to the management of obesity in women planning pregnancy are needed. METHODS/DESIGN:This study, a two-arm, parallel group, randomized control trial, will be conducted at the Metabolic Disorders Centre, University of Melbourne. This trial will recruit 164 women aged 18-38 years with a body mass index of 30-55 kg/m2 who plan to conceive in the next 6-12 months. Women will be randomized to one of two 12-week interventions (Group A and Group B). Group A will aim for modest weight loss (MWL; ??3% body weight) using a hypocaloric diet. Group B will aim for substantial weight loss (SWL; 10-15% body weight) using a modified very low energy diet (VLED) program. All participants will be asked to comply with National Health and Medical Research Council (NHMRC) guidelines for exercise and will be provided with standard pre-pregnancy advice according to Royal Australian and New Zealand College of Obstetrics and Gynaecology guidelines. All participants will then be observed for the subsequent 12 months. If pregnancy occurs within the 12-month follow-up period, data on weight and metabolic status of the mother, and pregnancy outcomes of mother and offspring will be recorded. The primary outcome is maternal fasting plasma glucose at 26-28 weeks' gestation, given that this is known to correlate with pregnancy outcomes. Time to conception, live birth rate, gestational weight gain, and a composite of adverse pregnancy outcomes for mother and baby will comprise the secondary outcomes. DISCUSSION:There is increasing emphasis on obese women losing weight before conception. To date, no randomized controlled trial has demonstrated an effective means of weight loss that results in improved pregnancy outcomes for both mother and baby. This study intends to determine if substantial pre-conception weight loss, achieved using a VLED, improves pregnancy outcomes for mother and baby when compared with standard care. This research will potentially change clinical care of an obese woman planning pregnancy. TRIAL REGISTRATION:ANZCTR, 12,614,001,160,628 . Registered on 5 November 2014.

Project description:BackgroundWomen experience changes both physically and psychologically during their transition to motherhood. The postnatal period is a critical time for women to develop maternal self-efficacy. Mobile health interventions may offer a way to reach women during this critical period to offer support and information. Essential Coaching for Every Mother is a text message program that seeks to educate and support women during the first 6 weeks postpartum.ObjectiveThe primary effectiveness objective is to compare the effectiveness of the Essential Coaching for Every Mother program on maternal psychosocial outcomes (self-efficacy, social support, postpartum depression, and postpartum anxiety) immediately after the intervention and 6 months postpartum, collectively as well as stratified by parity. The primary implementation objective is to evaluate the implementation extent and quality of the Essential Coaching for Every Mother program.MethodsThis will be a hybrid type 1 effectiveness-implementation randomized controlled trial. A total of 140 mothers-to-be or new mothers from Nova Scotia will be recruited and randomized to the intervention or control arm, stratified by parity. The intervention arm will receive the Essential Coaching for Every Mother program, which consists of 53 messages sent twice a day for the first 2 weeks and daily for weeks 3 through 6. The control group will receive usual care. Messages are personalized based on the infant's age and the woman's self-selected preference for breastfeeding or formula feeding and tailored with the infant's name and gender. Women can enroll in the program if they are ≥37 weeks pregnant or within 10 days postpartum, with the first message designed to be sent on the second evening after birth. The actual number of messages received will vary based on the timing of enrollment and the infant's date of birth. Participants will complete questionnaires assessing self-efficacy, social support, and postpartum depression and anxiety at baseline (enrollment after birth) and 6 weeks (postintervention) and 6 months postpartum. Implementation data will be collected throughout the trial, and evaluation feedback will be collected at 6 weeks from women who received the intervention.ResultsRecruitment for this study started on January 5, 2021, and is currently ongoing, with an anticipated date of recruitment completion of January 2022.ConclusionsThis study will assess the effectiveness of a postpartum text message program to improve maternal self-efficacy and social support while decreasing postpartum depression and anxiety. It will also shed light on the implementation effectiveness of the program.Trial registrationClinicalTrials.gov NCT04730570; https://clinicaltrials.gov/ct2/show/NCT04730570.International registered report identifier (irrid)DERR1-10.2196/27138.

Project description:BACKGROUND:Complications of prematurity are a leading cause of newborn death in Malawi. Despite early adoption of Kangaroo mother care (KMC), coverage remains low and women have expressed challenges in using the traditional wrapper-chitenje. In 2016, a study was conducted to evaluate the acceptability and effectiveness of a customized KMC wrap in improving adherence to KMC practices among mothers. METHODS:Mother-baby dyads (301) were randomized to receive either a customized CarePlus Wrap developed by Lærdal Global Health or a traditional chitenje. Enrolled mother-baby dyads were assessed in the KMC ward at 2-3 days after of admission, and then again at 7-15 days post-discharge. Topics covered included skin-to-skin practices, breastfeeding, perceptions of the wrap, and family/community support. Chi square tests were used to assess associations between wrap type and KMC practices. The study received ethics approval. RESULTS:This study found that a customized KMC wrap is highly acceptable to women and improved skin-to-skin practices in facility-based KMC: 44% of mothers using a customized wrap reported 20 or more hours per day, compared to 33% of mothers using the traditional chitenje. Women using the customized wrap reported being comfortable in keeping the baby in skin-to-skin position more often than women using the chitenje (96% vs. 71%), and they were able to tie on the wrap themselves (86% vs. 10%). At the time of discharge from KMC, more women who used the customized wrap were satisfied with the wrap than those who used the traditional chitenje (94% vs. 56%). The customized wrap did not appear to impact other newborn practices, such as breastfeeding. CONCLUSIONS:This study provides evidence that a customized KMC wrap is highly acceptable to mothers, and it can contribute to better skin-to-skin practices. Use of a customized wrap may be one mechanism to support mothers in practicing KMC and skin-to-skin contact in addition to other interventions.

Project description:BACKGROUND:During the postpartum visit, health care providers address issues with short- and long-term implications for maternal and child health. Women with Medicaid insurance are less likely to return for a postpartum visit compared with women with private insurance. Behavioral economics acknowledges that people do not make exclusively rational choices, rather immediate gratification, cognitive and psychological biases, and social norms influence decision making. Drawing on insights from decision science, behavioral economists have examined how these biases can be modulated through carefully designed interventions. We have developed a Web-based tool, Healthy Beyond Pregnancy, that incorporates empirically derived concepts of behavioral economics to improve adherence rates to the postpartum visit. OBJECTIVES:The primary objectives of this pilot study were to (1) refine and assess the usability of Healthy Beyond Pregnancy and (2) assess the feasibility of a randomized controlled trial (RCT) of the intervention. METHODS:We used a multistep process and multidisciplinary team of maternal-fetal medicine physicians, a behavioral economist, and researchers with expertise in behavioral interventions to design Healthy Beyond Pregnancy. We assessed the usability of the program with the Post-Study System Usability Questionnaire (PSSUQ), a validated 7-point scale, and semistructured interviews with postpartum women. We then conducted a feasibility trial to determine the proportion of eligible women who were willing to participate in an RCT of Healthy Beyond Pregnancy and the proportion of women willing to complete the Web-based program. Exploratory outcomes of the pilot trial included attendance at the postpartum visit, uptake of long-acting reversible contraception, and uptake of any contraception. RESULTS:The median PSSUQ score for Healthy Beyond Pregnancy was 6.5 (interquartile range: 6.1-7) demonstrating high usability. Semistructured interviews (n=10) provided in-depth comments about users' experience and further improved the program. A total of 34 postpartum women with Medicaid insurance were approached for the pilot trial, and 30 (88%) were consented and randomized. All women randomized to Healthy Beyond Pregnancy completed the Web-based program, had text-enabled cell phones, and were willing to receive text messages from the study team. Women in the Healthy Beyond Pregnancy arm were more likely to return for a postpartum visit compared with women in the control arm with 85% of women in Healthy Beyond Pregnancy returning versus 53% in the control arm (odds ratio in the Healthy Beyond Pregnancy group: 5.3; 95% CI 0.9-32.0; P=.06). CONCLUSIONS:We have developed a highly usable and acceptable Web-based program designed to increase attendance at the postpartum visit. Our pilot trial demonstrates that women are willing and able to participate in a randomized trial of a Web-based program and text messaging system. TRIAL REGISTRATION:Clinicaltrials.gov NCT03296774; https://clinicaltrials.gov/ct2/show/NCT03296774 (Archived by WebCite at http://www.webcitation.org/6tpgXFzyk).

Dataset Information

A Randomized Controlled Trial of Innovative Postpartum Care Model for Mother-Baby Dyads.

Publications

A Randomized Controlled Trial of Innovative Postpartum Care Model for Mother-Baby Dyads.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets